Understanding vaccine immunity in patients treated with CAR-T cell therapy
Official title: Restoration of Immunity to Vaccine Preventable Diseases After CART-T Cell Therapy
Run by Insel Gruppe AG, University Hospital Bern · NCT06333275 · Data updated 2026-11-12
This study is trying to see how well vaccines work in patients with blood cancers who have had CAR-T therapy and if they need different vaccination plans to stay protected.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 1 site (Bern) |
| Status | Recruiting |
| Started | November 14, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2026 |
| Registry record updated | March 27, 2024 |
| Trial ID | NCT06333275 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who are suffering from specific B-cell malignancies and are planned for CAR-T cell therapy.
✕Probably not a fit
Patients who have already started CAR-T cell therapy or are under 18 years old may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to investigate vaccine immunity in patients with B-cell malignancies who have undergone chimeric antigen receptor T-cell (CAR-T) therapy. It seeks to determine whether these patients lose protection against vaccine-preventable diseases, assess the adequacy of current re-vaccination recommendations, and evaluate the speed at which vaccine protection is lost post-therapy. Additionally, the study will explore clinical and immunological factors that may predict vaccine response in these patients. By gathering this information, the study hopes to improve vaccination strategies for CAR-T therapy recipients.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and restore immunity in patients undergoing CAR-T therapy, improving their overall health outcomes.
How similar studies have gone: While this study addresses a specific aspect of vaccine immunity in CAR-T therapy recipients, similar studies have not been widely conducted, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient ≥ 18 years old * Suffering from a B-cell malignancy (B-cell acute lymphoblastic leukemia (ALL), B-cell non-hodgkin lymphoma (NHL), Follicular lymphoma (FL), Mantle Cell Lymphoma (MCL), Multiple myeloma (MM)) * Planned for a CAR-T cell therapy * Provided written informed consent Exclusion Criteria: * Previous or already started CAR-T cell therapy * \< 18 years old * Lack of consent
Where it's running
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University Hospital Bern
Bern, Switzerland Recruiting
Study contacts
- Principal investigator: Christine Thurnheer Zürcher, PD, MD — University Hospital Bern, Switzerland
- Study coordinator: Lukas N Baumann, MD
- Email: lukas.baumann2@insel.ch
- Phone: +41 31 664 3069
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.